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Efgartigimod in Sjögren's disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded,

Isabelle Peene1, Gwenny M Verstappen2, Suzanne Arends2

  • 1Department of Rheumatology, Ghent University Hospital, Ghent, Belgium; VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.

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Summary

Efgartigimod showed promise in a Phase 2 trial for Sjögren's disease (SjD), with numerically higher response rates in key endpoints compared to placebo. Further Phase 3 studies are recommended for this autoimmune condition.

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Area of Science:

  • Rheumatology
  • Immunology
  • Clinical Pharmacology

Background:

  • Sjögren's disease (SjD) is a chronic autoimmune disorder affecting exocrine glands.
  • Current treatments for SjD lack efficacy and have significant side effects.
  • Efgartigimod is an FcRn antagonist investigated for autoimmune conditions.

Purpose of the Study:

  • To evaluate the efficacy and safety of intravenous efgartigimod in adults with Sjögren's disease.
  • To establish proof of concept for efgartigimod in SjD treatment.

Main Methods:

  • A randomized, double-blinded, placebo-controlled, phase 2 study (RHO) was conducted.
  • Participants received efgartigimod IV (10 mg/kg) or placebo weekly for 24 weeks.
  • Primary endpoint: proportion of Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) responders at week 24.

Main Results:

  • A numerically higher proportion of efgartigimod-treated participants were CRESS responders (45.5% vs. 11.1% for placebo).
  • Efgartigimod showed higher scores on 4 of 5 CRESS items and the candidate Sjögren's Tool for Assessing Response (cSTAR).
  • Treatment-emergent adverse events were mostly grade 1 or 2.

Conclusions:

  • The RHO study provides proof of concept for efgartigimod in Sjögren's disease.
  • Efgartigimod demonstrates potential as a novel therapeutic agent for SjD.
  • Further investigation in a Phase 3 trial is warranted.